Drugplain

OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL

OXYMETAZOLINE HYDROCHLORIDE · SPRAY · CHAIN DRUG MARKETING ASSOCIATION INC.

10 Recalls on Record
Plain English

Oxymetazoline hydrochloride nasal spray is a decongestant that helps relieve nasal congestion from colds, allergies, and sinus problems by narrowing blood vessels in the nasal passages. It is available over-the-counter without a prescription.

Key Facts

Brand Name
OXYMETAZOLINE HYDROCHLORIDE
Generic Name
OXYMETAZOLINE HYDROCHLORIDE
NDC Code (Product)
63868-676
Manufacturer
CHAIN DRUG MARKETING ASSOCIATION INC.
Strength
.05 g/100mL
Dosage Form
SPRAY
Route
NASAL
Marketing Status
Application #
M012
Marketing Start
02/01/2021

Recall History

10 Recalls on Record
Class II08/03/2018

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

TerminatedVoluntary: Firm initiated
Class II08/03/2018

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

TerminatedVoluntary: Firm initiated
Class II12/28/2023

Seaway Pharma Inc.

CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.

OngoingVoluntary: Firm initiated
Class II08/03/2018

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

TerminatedVoluntary: Firm initiated
Class II08/03/2018

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

TerminatedVoluntary: Firm initiated
Class II12/28/2023

Seaway Pharma Inc.

CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.

OngoingVoluntary: Firm initiated
Class II08/03/2018

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

TerminatedVoluntary: Firm initiated
Class II08/03/2018

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

TerminatedVoluntary: Firm initiated
Class II08/03/2018

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

TerminatedVoluntary: Firm initiated
Class II08/03/2018

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue46 reports
nausea43 reports
pain40 reports
diarrhoea37 reports
product dose omission issue34 reports
drug ineffective28 reports
headache27 reports
off label use27 reports
pruritus27 reports
cough25 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies shrinks swollen nasal membranes so you can breathe more freely

Dosage & Administration

Directions adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10-12 hours. Do not exceed 2 doses in any 24-hour period. children under 6 years of age: ask a doctor Shake well before use. to spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

Warnings

Warnings Ask a doctor before use if you have heart disease thyroid disease high blood pressure diabetes trouble urinating due to an enlarged prostate gland When using this product do not use more than directed do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur use of this container by more than one person may spread infection

Frequently Asked Questions

What is OXYMETAZOLINE HYDROCHLORIDE used for?

Oxymetazoline hydrochloride nasal spray is a decongestant that helps relieve nasal congestion from colds, allergies, and sinus problems by narrowing blood vessels in the nasal passages. It is available over-the-counter without a prescription.

Is OXYMETAZOLINE HYDROCHLORIDE a controlled substance?

OXYMETAZOLINE HYDROCHLORIDE is not classified as a controlled substance by the DEA.

What is the generic name for OXYMETAZOLINE HYDROCHLORIDE?

The generic name for OXYMETAZOLINE HYDROCHLORIDE is OXYMETAZOLINE HYDROCHLORIDE. There are 12 other brand versions of OXYMETAZOLINE HYDROCHLORIDE.

What is the NDC code for OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL?

The NDC (National Drug Code) for OXYMETAZOLINE HYDROCHLORIDE .05 g/100mL is 63868-676, listed by CHAIN DRUG MARKETING ASSOCIATION INC..